Updating the Common Rule

New national regulations on researching humans needs more public input

December 21, 2015

“We need to assure that the public has a real voice and can make a meaningful contribution to the changes that will affect us all.”
– Feinberg's Kelly Michelson, Shannon Haymond, Erin Paquette, Susanna McColley, Lauren Sorce and Sabrina Derrington

Our world’s recent history includes troubling examples of inhumane research on human subjects. There were the brutal experiments conducted on Jewish people in Nazi concentrations camps. From 1932 to 1972, researchers involved in the Tuskegee Syphilis Experiment withheld penicillin treatment from infected African-American men to study the natural progression of syphilis.

Today, these kinds of abuses are rare. This is due in part to the Common Rule, a set of federal regulations describing guiding oversight of research involving human subjects in the United States.

Twenty five years after their development in 1991, the Department of Health and Human Services (DHHS) has proposed significant changes to the Common Rule. Before anything permanently changes, the public has a chance to comment on the proposed changes.

If this is the first time you are hearing about the Common Rule or the proposed changes, you’re not alone. We believe DHHS should do more to engage the general public in this process.

First though, why are these changes even necessary?

The short answer is that research today is different than it was 25 years ago and the rules need to reflect those changes. For example, today, studies involving multiple centers or hospitals are often preferred to those done at one site. Currently, most multi-centered studies require that researchers gain permission from each site to conduct their research, which some argue causes unnecessary delays and higher costs. A proposed change would mandate that most multi-center research rely on a single review board for obtaining approval.

Together, the six of us are studying parents’ views about conducting research with leftover specimens obtained from hospitalized children. Currently investigators can use such specimens, provided they are not linked to personal information, without obtaining consent. The proposed changes would require investigators to obtain consent before using such specimens. While giving individuals more control over their specimens, this change could mean fewer specimens for research and therefore fewer answers to important medical questions that could improve patient care.

Overall, updating the Common Rule is meant to better protect research subjects, help build public trust, and improve the effectiveness and efficiency of the oversight system. But if the public doesn’t have a chance to voice their opinions, changes may be made that do not reflect what they would want. Ironically, some changes could make conducting important research more difficult and expensive without adding benefit. The result could be further delays in developing life-saving therapies for people suffering from illness.

In theory, the public does have a chance to have their say.

When agencies make laws, called rules or regulations, public notification is done through theFederal Register,a government publication in which agencies publish notices about their yearly plans. An agency must publish an official notice of any proposed changes. This notice is followed by a public comment period. The original public comment period for the Common Rule changes was from September 8, 2015 to December 7, 2015. DHHS recently announced an extension until January 6, 2016.

The first problem is that most people don’t even know the Common Rule exists, let alone that they can comment on what it says. The second problem is that the document is sufficiently complicated that even people with a sophisticated understanding of clinical research have trouble deciphering it.

Despite our collective extensive experience of close to 100 combined years in clinical research, we were confounded by the complex language in the 131 page document of proposed changes. Do most US citizens understand what an assurance-holding organization is? Or what is meant by secondary research? The summary alone is written at a grade level beyond high school.

A number of things could help.

First, social media could be used to spread the word in the remaining few weeks of the current comment period.

Second, DHHS should actively reach out to patient advocacy groups and foundations with an interest in healthcare.

Third, we need plain language fact sheets explaining the proposed changes. Scenarios describing where the Common Rule applies and how the proposed changes would have an impact could help.

Fourth, make the comment website easier to navigate so that the public can easily review submitted comments.

Fifth, consider extending the comment period.

The rules for conducting research are changing. We need to assure that the public has a real voice and can make a meaningful contribution to the changes that will affect us all.